FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to infusion pumps and regulatory matters associated thereto. The document addresses the most important...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to design control. The document covers the regulatory matters related to design verification and...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published guidance dedicated to the submission of premarket notifications for magnetic resonance diagnostic devices. The latest version of the...
FDA
The Food and Drug Administration (FDA), the US regulating authority, has published guidance describing technical considerations for non-clinical assessment of medical devices containing nitinol. The present document constitutes a final version of the draft guidance...
FDA
The Food and Drug Administration (FDA) has published a guidance document dedicated to the basic safety and essential performance of medical electrical equipment, medical electrical systems, and laboratory medical equipment. The document provides the standards-specific...
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